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Completed

NCT Number: NCT04235647

A Nurse Led Intervention to Promote Physical Activity

Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.

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Key information

Conditions

Sedentary Behavior Behavior Cardiovascular Risk Factor

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NZOZ Arnika

Stare Babice, Ul. Rynek 10, 05-082, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
  • history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.

Exclusion criteria

  • unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
  • inability to undertake physical activity due to orthopedic reasons or other disabilities;
  • planned changes in pharmacological treatment during the study period;
  • lack of will to participate in the study and to sign the the written informed consent for the participation in the study.

Treatment and study plan

Nurse led tutorial on lifestyle management and pedometer hand-out

Other

Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out

Steps goal setting and supporting phone calls

Other

A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks

Primary outcomes

  1. Change in total body weight

    Time frame: 3 months

Secondary outcomes

  1. Change in body mass index (BMI)

    Time frame: 3 months

  2. Change in waist circumference

    Time frame: 3 months

  3. Change in resting heart rate

    Time frame: 3 months

  4. Change in resting blood pressure

    Time frame: 3 months

  5. Change in total cholesterol concentration at fasting

    Time frame: 3 months

  6. Change in glucose concentration at fasting

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Warsaw, Poland

Other

Collaborators

  • Józef Piłsudski University of Physical Education

Registry information

Official study title

A Nurse Led Intervention to Promote Physical Activity in Sedentary Older Adults With Cardio-vascular Risk Factors in the Outpatient Setting - a Randomized Controlled Trial

Acronym: STEP-IT-UP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 22, 2020
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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